BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4942233 · Received July 23, 2015

    Report

    Report Number
    1052693-2015-01262
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LO BLOOD GLUCOSE RESULT. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 90 MG/DL. TESTING NOT PERFORMED DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CUSTOMER IS COMPARING RESULTS TO TWO OTHER COMPETITOR'S METERS BUT UNABLE TO PROVIDE EXACT RESULTS OR METER BRAND NAME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 1: LO, (B)(6) 2015, 04:43 PM, FASTING: YES; 2: LO, (B)(6) 2015, 04:33 PM, FASTING: YES; 3: LO, (B)(6) 2015, 04:32 PM, FASTING: YES; 4: 88 MG/DL, (B)(6) 2015, 04:06 PM, FASTING: NO; 5: 93 MG/DL, (B)(6) 2015, 02:57 PM, FASTING: NO. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479334 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2153

    Patients

    Seq Age Sex Outcome Treatment
    1